Fluid diversion mechanism for bodily-fluid sampling

ABSTRACT

An apparatus includes a housing, a flow control mechanism, and an actuator. At least a portion of the flow control mechanism is movably disposed within the housing. The apparatus further includes an inlet port and an outlet port, and defines a fluid reservoir. The outlet port is fluidically coupled to a second fluid reservoir and is fluidically isolated from the first fluid reservoir. The actuator is configured to move the flow control mechanism between a first configuration, in which the inlet port is placed in fluid communication with the fluid reservoir such that the fluid reservoir receives a first flow of bodily-fluid, and a second configuration, in which the inlet port is placed in fluid communication with the outlet port.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. ProvisionalApplication Ser. No. 61/546,954, filed Oct. 13, 2011, entitled,“Innovation for Reducing Blood Culture Contamination: Initial SpecimenDiversion Technique,” the disclosure of which is hereby incorporated byreference in its entirety.

BACKGROUND

Embodiments described herein relate generally to the parenteralprocurement of bodily-fluid samples, and more particularly to devicesand methods for parenterally-procuring bodily-fluid samples with reducedcontamination from microbes or other contaminants exterior to thebodily-fluid source, such as dermally-residing microbes.

Health care practitioners routinely perform various types of microbialtests on patients using parenterally-obtained bodily-fluids. Patientsamples (e.g., bodily-fluids) are sometimes tested for the presence ofone or more potentially undesirable microbes, such as bacteria, fungi,or yeast (e.g., Candida). Microbial testing may include incubatingpatient samples in one or more sterile vessels containing culture mediathat is conducive to microbial growth. Generally, when microbes testedfor are present in the patient sample, the microbes flourish over timein the culture medium. After a pre-determined amount of time (e.g., afew hours to several days), the culture medium can be tested for thepresence of the microbes. The presence of microbes in the culture mediumsuggests the presence of the same microbes in the patient sample which,in turn, suggests the presence of the same microbes in the bodily-fluidof the patient from which the sample was obtained. Accordingly, whenmicrobes are determined to be present in the culture medium, the patientmay be prescribed one or more antibiotics or other treatmentsspecifically designed to treat or otherwise remove the undesiredmicrobes from the patient.

Patient samples, however, can sometimes become contaminated duringprocurement. One way in which contamination of a patient sample mayoccur is by the transfer of microbes from a bodily surface (e.g.,dermally-residing microbes) dislodged during needle insertion into apatient and subsequently transferred to a culture medium with thepatient sample. The bodily surface microbes may be dislodged eitherdirectly or via dislodged tissue fragments, hair follicles, sweat glandsand other adnexal structures. The transferred microbes may thrive in theculture medium and eventually yield a positive microbial test result,thereby falsely indicating the presence of such microbes in vivo. Suchinaccurate results are a concern when attempting to diagnose or treat asuspected illness or condition. For example, false positive results frommicrobial tests may result in the patient being unnecessarily subjectedto one or more anti-microbial therapies, which may cause serious sideeffects to the patient including, for example, death, as well as producean unnecessary burden and expense to the health care system.

As such, a need exists for improved bodily-fluid transfer devices andmethods that reduce microbial contamination in bodily-fluid testsamples.

SUMMARY

Devices for parenterally-procuring bodily-fluid samples with reducedcontamination from microbes exterior to the bodily-fluid source, such asdermally-residing microbes, are described herein. In some embodiments,an apparatus includes a housing, a flow control mechanism, and anactuator. At least a portion of the flow control mechanism is movablydisposed within the housing. The apparatus further includes an inletport and an outlet port, and defines a fluid reservoir. The outlet portis fluidically coupled to a second fluid reservoir and is fluidicallyisolated from the first fluid reservoir. The actuator is configured tomove the flow control mechanism between a first configuration, in whichthe inlet port is placed in fluid communication with the fluid reservoirsuch that the fluid reservoir receives a first flow of bodily-fluid, anda second configuration, in which the inlet port is placed in fluidcommunication with the outlet port.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a bodily-fluid transfer deviceaccording to an embodiment.

FIG. 2 is a perspective view of a bodily-fluid transfer device accordingto an embodiment.

FIG. 3 is an exploded view of the bodily-fluid transfer device of FIG.2.

FIG. 4 is a perspective view of a housing included in the bodily-fluidtransfer device illustrated in FIG. 2.

FIG. 5 is a cross-sectional view of the housing illustrated in FIG. 4taken along the line X₂-X₂.

FIG. 6 is a perspective view of an actuator included in the bodily-fluidtransfer device of FIG. 2.

FIG. 7 is an exploded perspective view of a flow control mechanismincluded in the bodily-fluid transfer device of FIG. 2.

FIG. 8 is a cross-sectional view of the bodily-fluid transfer device ofFIG. 2 taken along the line X₁-X₁, in a first configuration.

FIG. 9 is an enlarged view of the region labeled Z in FIG. 8.

FIGS. 10 and 11 are cross-sectional views of the bodily-fluid transferdevice of FIG. 2 taken along the line X₁-X₁, in a second and thirdconfiguration, respectively.

FIG. 12 is a perspective view of the bodily-fluid transfer device ofFIG. 3, in the third configuration.

FIG. 13 is a perspective view of a bodily-fluid transfer deviceaccording to an embodiment.

FIG. 14 is an exploded view of the bodily-fluid transfer device of FIG.13.

FIG. 15 is a perspective view of a first control member included in hebodily-fluid transfer device of FIG. 13.

FIGS. 16-18 are cross-sectional views of the bodily-fluid transferdevice taken along the line X₃-X₃ in 12, in a first, second, and thirdconfiguration, respectively.

DETAILED DESCRIPTION

Devices for parenterally-procuring bodily-fluid samples with reducedcontamination from microbes exterior to the bodily-fluid source, such asdermally-residing microbes, are described herein. In some embodiments,an apparatus includes a housing, a flow control mechanism, and anactuator. At least a portion of the flow control mechanism is movablydisposed within the housing. The apparatus further includes an inletport and an outlet port, and defines a first fluid reservoir. The outletport is fluidically coupleable to a second fluid reservoir, fluidicallyisolated from the first fluid reservoir. The actuator is configured tomove the flow control mechanism between a first configuration, in whichthe inlet port is placed in fluid communication with the first fluidreservoir such that the first fluid reservoir receives a flow ofbodily-fluid, and a second configuration, in which the inlet port isplaced in fluid communication with the outlet port such that the secondfluid reservoir can receive a flow of bodily-fluid.

In some embodiments, a bodily-fluid transfer device can be configured toselectively divert a first, predetermined amount of a flow of abodily-fluid to a first fluid reservoir before permitting the flow of asecond amount of the bodily-fluid into a second fluid reservoir. In thismanner, the second amount of bodily-fluid can be used for diagnostic orother testing, while the first amount of bodily-fluid, which may containmicrobes from a bodily surface, is isolated from the bodily-fluid to betested.

In some embodiments, a bodily-fluid transfer device is configured toautomatically move from a first configuration to a second configuration,for example, without requiring an input or other action by a health carepractitioner. In some embodiments, the bodily-fluid transfer deviceprevents bodily-fluid from flowing or otherwise being introduced into asecond fluid reservoir before at least a first amount of bodily-fluid(e.g., a predetermined amount) is first introduced into a first fluidreservoir.

As referred to herein, “bodily-fluid” can include any fluid obtainedfrom a body of a patient, including, but not limited to, blood,cerebrospinal fluid, urine, bile, lymph, synovial fluid, serous fluid,pleural fluid, amniotic fluid, and the like, or any combination thereof.

As used herein, the term “set” can refer to multiple features or asingular feature with multiple parts. For example, when referring to setof walls, the set of walls can be considered as one wall with distinctportions, or the set of walls can be considered as multiple walls.Similarly stated, a monolithically constructed item can include a set ofwalls. Such a set of walls can include, for example, multiple portionsthat are in discontinuous from each other. A set of walls can also befabricated from multiple items that are produced separately and arelater joined together (e.g., via a weld, an adhesive or any suitablemethod).

As used in this specification, the words “proximal” and “distal” referto the direction closer to and away from, respectively, a user who wouldplace the device into contact with a patient. Thus, for example, the endof a device being actuated by the user would be the proximal end, whilethe opposite end of the device would be the distal end of the device.

As used in this specification, the terms “first, predetermined amount”and “first amount” describe a given amount of bodily-fluid configured tobe received or contained by a pre-sample reservoir (also referred toherein as a “first reservoir”). While the term “first amount” does notexplicitly describe a predetermined amount, it should he understood thatthe first amount is the first, predetermined amount unless explicitlydescribed differently.

FIG. 1 is a schematic illustration of a portion of a bodily-fluidtransfer device 100, according to an embodiment. Generally, thebodily-fluid transfer device 100 (also referred to herein as “fluidtransfer device” or “transfer device”) is configured to permit thewithdrawal of bodily-fluid from a patient such that a first portion oramount of the withdrawn fluid is diverted away from a second portion oramount of the withdrawn fluid that is to be used as a biological sample,such as for testing for the purpose of medical diagnosis and/ortreatment. In other words, the transfer device 100 is configured totransfer a first, predetermined amount of a bodily-fluid to a firstcollection reservoir and a second amount of bodily-fluid to one or morebodily-fluid collection reservoirs fluidically isolated from the firstcollection reservoir, as described in more detail herein.

The transfer device 100 includes a housing 101, an inlet port 107, anoutlet port 110, a flow control mechanism 130, an actuator 170, a firstfluid reservoir 180 (also referred to herein as “first reservoir”), andoptionally a second fluid reservoir 190 (also referred to herein as“second reservoir”), different than the first reservoir 180. The housing101 can house at least a portion of the flow control mechanism 130 andthe first reservoir 180 In some embodiments, the housing 101 can alsohouse at least a portion of the actuator 170 and/or at least a portionof the second reservoir 190. The housing 101 can be any suitable shape,size, or configuration and is described in further detail herein withrespect to specific embodiments.

In some embodiments, the inlet port 107 and the outlet port 110 can beincluded in (e.g., monolithically formed with) or coupled to the housing101. In other embodiments, the inlet port 107 and the outlet port 110can be included in or coupled to the flow control mechanism 130 and canextend through a portion of the housing 101. As shown in FIG. 1, theinlet port 107 can be, at least temporarily, physically and fluidicallycoupled to a medical device defining a pathway P for withdrawing and/orconveying the bodily-fluid from the patient to the transfer device 100.For example, the inlet port 107 can be a Luer-Lok® or the likeconfigured to be physically and fluidically coupled to a needle, acannula, or other lumen-containing device. In other embodiments, theinlet port 107 can be monolithically formed with at least a portion ofthe lumen-containing device. In this manner, the inlet port 107 canreceive the bodily-fluid from the patient via the pathway P. The outletport 110 is configured to be fluidically coupled to the second fluidreservoir 190, as further described herein.

The first reservoir 180 can be any suitable reservoir for containing abodily-fluid. For example, in some embodiments, the first reservoir 180can be formed by a portion of the flow control mechanism 130 (e.g.,defined by a set of walls of the flow control mechanism 130). In someembodiments, the first reservoir 180 can be formed or defined by aportion of the flow control mechanism 130 and a portion of the housing101. In other embodiments, the first reservoir 180 can be self-contained(e.g., such as a bladder or the like) and be disposed within a portionof the housing 101 and/or the flow control mechanism 130. In someembodiments, the first reservoir 180 can be a pre-sample reservoir suchas those described in detail in U.S. Pat. No. 8,197,420 (“the '420Patent”), the disclosure of which is incorporated herein by reference inits entirety. In this manner, the first reservoir 180 can be, at leasttemporarily, placed in fluid communication with the inlet port 107 suchthat the first reservoir 180 can receive and contain the first,predetermined amount of the bodily-fluid. In some embodiments, the firstreservoir 180 is configured to contain the first amount of thebodily-fluid such that the first amount is fluidically isolated from asecond amount of the bodily-fluid (different than the first amount ofbodily-fluid) that is subsequently withdrawn from the patient.

The second reservoir 190 can be any suitable reservoir tier containing abodily-fluid, including, for example, a sample reservoir as described inthe '420 Patent incorporated by reference above. In some embodiments,the second reservoir 190 can be substantially similar to or the same asknown sample containers such as, for example, a Vacutainer® or the like.The second reservoir 190 is configured to be fluidically coupled to theoutlet port 110 of the transfer device 100. For example, in someembodiments, the second reservoir 190 is physically (either directly orvia an intervening structure such as sterile flexible tubing) andfluidically coupled to the outlet port 110. In other embodiments, thesecond reservoir 190 can be moved relative to the outlet port 110 toplace the second reservoir 190 in fluid communication with the outletport 110, as described herein with respect to specific embodiments.

The second reservoir 190 is configured to receive and contain the secondamount of the bodily-fluid. For example, the second amount ofbodily-fluid can be an amount withdrawn from the patient subsequent towithdrawal of the first amount. In some embodiments, the secondreservoir 190 is configured to contain the second amount of thebodily-fluid such that the second amount is fluidically isolated fromthe first amount of the bodily-fluid. As used in this specification, theterm “second amount” describes an amount of bodily-fluid configured tobe received or contained by the second reservoir 190. In someembodiments, the second amount can be any suitable amount ofbodily-fluid and need not be predetermined. In other embodiments, thesecond amount received and contained by the second reservoir 190 is asecond predetermined amount.

The flow control mechanism 130 of the transfer device 100 is movablydisposed within the housing 101 between a first configuration and asecond configuration and defines, at least partially, a first fluid flowpath 181 and a second fluid flow path 191, as described in furtherdetail herein. The flow control mechanism 130 can be any suitable shape,size, or configuration. For example, in some embodiments, the flowcontrol mechanism 130 can include multiple components. In suchembodiments, a first set of one or more components can move togetherwith and/or relative to a second set of one or more components such thatthe flow control mechanism 130 is moved between the first configurationand the second configuration,

The actuator 170 of the transfer device 100 can be operably coupled tothe flow control mechanism 130 (e,g., either directly or indirectly viaan intervening structure). In this manner, the actuator 170 can beconfigured to move the flow control mechanism 130 relative to thehousing 101 between the first configuration and the secondconfiguration. For example, the actuator 170 can be movable between afirst position corresponding to the first configuration of the flowcontrol mechanism 130, and a second position, different than the firstposition, corresponding to the second configuration of the flow controlmechanism 130. In some embodiments, the actuator 170 is configured forunidirectional movement. For example, the actuator 170 can be moved fromits first position to its second position, but cannot be moved from itssecond position to its first position. In this manner, the flow controlmechanism 130 is prevented from being moved to its second configurationbefore its first configuration, thus requiring that the first amount ofthe bodily-fluid be directed to the first reservoir 180 and not thesecond reservoir 190, as further described herein.

In some embodiments, the actuator 170 can move the flow controlmechanism 130 in a translational motion between the first configurationand the second configuration. For example, in some embodiments, the flowcontrol mechanism 130 can be in the first configuration when the flowcontrol mechanism 130 (or components included therein) is in a proximalposition relative to the housing 101. In such embodiments, the actuator170 can be actuated to move the flow control device 130 in the distaldirection to a distal position relative to the housing 101, therebyplacing the flow control mechanism 130 in the second configuration. Inother embodiments, the actuator 170 can be actuated to move the flowcontrol mechanism 130 in any suitable motion between the firstconfiguration and the second configuration (e.g., rotational). Examplesof suitable actuators are described in more detail herein with referenceto specific embodiments.

As described above, when the actuator 170 is in the first position andthe flow control mechanism 130 is in the first configuration, the inletport 107 is placed in fluid communication with the first fluid reservoir180 and the outlet port 110 is fluidically isolated from the inlet port107. More specifically, the bodily-fluid can flow within the first fluidflow path 181 between the inlet port 107 and the first reservoir 180such that the first reservoir 180 receives the first amount of thebodily-fluid. Similarly, when the actuator 170 is moved to the secondposition to place the flow control mechanism 130 in the secondconfiguration, the first reservoir 180 is fluidically isolated from theinlet port 107 and the outlet port 110 is placed in fluid communicationwith the inlet port 107. More specifically, the bodily-fluid can flowwithin the second fluid flow path 191 between the inlet port 107 and theoutlet port 110 such that the second reservoir 190 receives the secondamount of the bodily-fluid.

In some embodiments, the transfer device 100 is configured such that thefirst amount of bodily-fluid need be conveyed to the first reservoir 180before the transfer device 100 will permit the flow of the second amountof bodily-fluid to be conveyed through the outlet port 110 to the secondreservoir 190. In this manner, the transfer device 100 can becharacterized as requiring compliance by a health care practitionerregarding the collection of the first, predetermined amount (e.g., apre-sample) prior to a collection of the second amount (e.g., a sample)of bodily-fluid. Similarly stated, the transfer device 100 can beconfigured to prevent a health care practitioner from collecting thesecond amount, or the sample, of bodily-fluid into the second reservoir190 without first diverting the first amount, or pre-sample, ofbodily-fluid to the first reservoir 180. In this manner, the health carepractitioner is prevented from including (whether intentionally orunintentionally) the first amount of bodily-fluid, which is more likelyto contain bodily surface microbes, in the bodily-fluid sample to beused for analysis.

In some embodiments, the actuator 170 can have a third position and/or afourth position, different than the first and second positions, whichcorresponds to a third configuration of the flow control mechanism 130.When in the third configuration, the flow control mechanism 130 canfluidically isolate the inlet port 107 from both the first reservoir 180and the outlet port 110 simultaneously. Therefore, when the flow controlmechanism 130 is in its third configuration, flow of bodily-fluid fromthe inlet port 107 to either the first reservoir 180 or the secondreservoir 190 is prevented. For example, the actuator 170 can beactuated to place the flow control mechanism 130 in the firstconfiguration such that a bodily-fluid can flow from the inlet port 107to the first reservoir 180, then moved to the second configuration suchthat the bodily-fluid can flow from the inlet port 107 to the secondreservoir 190, then moved to the third configuration to stop the flow ofbodily-fluid into and/or through the outlet port 110. In someembodiments, the flow control mechanism 130 can be moved to the thirdconfiguration between the first configuration and the secondconfiguration. In some embodiments, the flow control mechanism 130 canbe in the third configuration before being moved to either of the firstconfiguration or the second configuration.

The transfer device 100 is one example of a device that can be used toimplement the Initial Specimen Diversion Technique (“ISDT”) described inU.S. Provisional Application Ser. No. 61/546,954 incorporated byreference above. For example, in some embodiments, the transfer device100 can be used by a phlebotomist (or technician otherwise trained inwithdrawing a bodily fluid from a patient) for the collection of asample blood culture. In some embodiments, phlebotomist or techniciancan use an alternative transfer device or other medical equipment toimplement the ISDT as described herein. For example, the phlebotomistcan prepare a venipuncture site with a skin antisepsis (e.g., 2%chiorhexidine, 70% alcohol) and insert a needle into the vein of thepatient such that a flow of blood is transferred away from the patient.The phlebotomist can divert a first, predetermined amount of blood to afirst reservoir, as described herein. The first amount of blood can, forexample, be sufficiently large such that dermally-residing microbeswhich may have been dislodged into the needle during the insertion ofthe needle into the vein may be washed into the first reservoir, therebyreducing the microbial contamination in the blood that is subsequentlyused as one or more samples for cultured microbial tests.

In some embodiments, the first amount of blood disposed within the firstreservoir (e.g., a pre-sample reservoir) can be associated with a sizeof a second reservoir and/or can be based on the desired volume ofsample blood. For example, in some embodiments, the first amount can beapproximately 0.5 mL to approximately 5 mL. In other embodiments, thefirst amount can be approximately 0.5 mL to approximately 2.0 mL of thebodily fluid. In still other embodiments, such as those used onpediatric patients, the first amount can be approximately 0.1 mL toapproximately 0.5 mL of the bodily fluid. Thus, the first amount can besufficiently large to adequately collect undesirable microbes whilemaintaining a substantially low risk of inducing nosocomial anemia in,for example, fragile patients.

With the first amount of blood disposed within the first reservoir, thephlebotomist can fluidically isolate the first reservoir and place thesecond reservoir in fluid communication with the needle. In this manner,the phlebotomist can transfer a second amount of blood to the secondreservoir that can be substantially free from, for example,dermally-residing microbes. Thus, the second amount of blood can be usedin any suitable test, such as a blood culture test, with a reducedlikelihood of false positives caused by undesirable microbes.

In some embodiments, with the second amount of blood collected thephlebotomist can remove the needle from the patient and discard thefirst amount of blood disposed within the first reservoir. In otherembodiments, the blood collected in the first reservoir can be used forconducting one or more non-culture tests, such as one or morebiochemical tests, blood counts, immunodiagnostic tests, cancer-celldetection tests, or the like.

In some embodiments, the ISDT can be used to reduce contaminationwithout impacting the specimen volume for blood culture. For example,the “diversion volume” or “pre-sample” can be collected without reducingthe volume collected for blood culture sampling. Thus, the ISDT reducescontamination without impacting blood culture sensitivity (e.g.,false-negatives) by, for example, minimizing the diversion volume. Asdescribed above, the ISDT can also be used to reduce contaminationwithout inducing nosocomial anemia in fragile patients. Said anotherway, the ISDT and/or transfer devices can be customized for differentapplications to balance the many competing factors (e.g., contamination,false-negatives, nosocomial anemia, etc.) associated with bodily fluidsampling. Thus, sample contamination can be sufficiently reduced without introducing other adverse consequences.

In some embodiments, higher diversion volumes can be used to furtherreduce the risk of sample contamination. For example, depending on thesensitivity of the test for which the sample is being collected, largervolumes of bodily-fluid can be diverted to further reduce the likelihoodof contamination where the test is highly sensitive to dermally-residingmicrobes and/or other contaminants.

In some embodiments, the diversion volume can be optimized for theneedle size being use to obtain the bodily-fluid sample. For example,smaller gauge needles tend to dislodge fewer dermally residing microbes,therefore, smaller diversion volumes can yield a similar contaminationreduction (e.g., number of false positives). Thus, smaller needles canbe used for smaller, difficult, or compromised veins/patients to reducethe diversion volume required for the IDST.

Referring now to FIGS. 2-12, a transfer device 200 includes a housing201, a flow control mechanism 230, an actuator 270, and a fluidreservoir 280 (also referred to herein as “first fluid reservoir” or“first reservoir”). As further described herein, the transfer device 200can be moved between a first, a second, and a third configuration todeliver a flow of a bodily-fluid that is substantially free frommicrobes exterior to the body, such as, for example, dermally residingmicrobes. The transfer device 200 can be any suitable shape, size, orconfiguration. For example, while shown in FIG. 2 as being substantiallycylindrical, the transfer device 200 can be polygonal (rectangular,hexagonal, etc.), oval (elliptical, egg-shaped, etc.), and/or any othernon-cylindrical shape.

The housing 201 includes a proximal end portion 202 and a distal endportion 203. The distal end portion 203 is a substantially closedportion of the housing 201 and includes one or more vents 214, asfurther described in detail herein. Moreover, a set of annular walls 205are configured to extend from the distal end portion 203 towards theproximal end portion 202 to define an inner volume 207 therebetween. Theproximal end portion 202 of the housing 201 is substantially open suchthat the inner volume 207 can receive at least a portion of the flowcontrol mechanism 230 (see e.g., FIG. 3).

As shown in FIGS. 4 and 5, the housing 201 further includes an inletport 208, an outlet port 210, and an engagement portion 212. Theengagement portion 212 extends from opposite sides of an outer surfaceof the walls 205, as shown in FIG. 4. The engagement portion 212includes one or more retention tabs 213 that can be placed in contactwith a portion of the actuator 270 to selectively limit a movement ofthe actuator 270 relative to the housing 201, as further described indetail herein. In addition, the engagement portion 212 can be engaged bya user during operation to facilitate the movement of the transferdevice 200 between the first, second, and third configurations, asfurther described herein.

The inlet port 208 included in the housing 201 is in fluid communicationwith the inner volume 207. More specifically, the inlet port 208 definesan inlet lumen 209 that is in fluid communication with the inner volume207. In this manner, the inlet port 208 extends from a portion of thewall 205 defining the inner volume 207 such that the inner volume 207can be placed in fluid communication with a volume substantially outsidethe housing 201, via the inlet lumen 209. The inlet port 208 can befluidically coupled to a medical device (not shown) that defines a fluidflow pathway for withdrawing and/or conveying the bodily-fluid from apatient to the transfer device 200. For example, the inlet port 208 canbe fluidically coupled to a needle or other lumen-containing device(e.g., flexible sterile tubing). Similarly stated, the inlet lumen 209defined by the inlet port 208 is placed in fluid communication with alumen defined by a lumen-containing device, when the lumen-containingdevice is coupled to the inlet port 208. Expanding further, when thelumen-containing device is disposed within a portion of a body of thepatient (e.g., within a vein of the patient), the inner volume 207 ofthe housing 201 is placed in fluid communication with the portion of thebody of the patient.

The outlet port 210 included in the housing 201 defines an outlet lumen211. As shown in FIG. 5, the outlet lumen 211 is configured to be influid communication with the inner volume 207 of the housing 201 (e.g.,the outlet lumen 211 extends through the wall 205 defining the innervolume 207). While not shown in FIGS. 2-12, the outlet port 210 can befluidically coupled to an external fluid reservoir (also referred toherein as “second fluid reservoir” or “second reservoir”), as furtherdescribed in detail herein.

As shown in FIG. 6, the actuator 270 includes a proximal end portion 271and a distal end portion 272. The proximal end portion 271 is asubstantially closed portion of the actuator 270 from which a set ofannular walls 273 extend. The annular walls 273 define an inner volume279 that can receive a portion of the housing 201 and a portion of theflow control mechanism 230. More specifically, the distal end portion272 of the actuator 270 is substantially open such that the portion ofthe housing 201 and the portion of the flow control mechanism 230 can bedisposed within the inner volume 279 of the actuator 270. In thismanner, the actuator 270 can be moved between a first position (e.g., aproximal position) and a second position (e.g., a distal position),relative to the housing 201, to move the transfer device 200 between thefirst, second, and third configuration.

The walls 273 of the actuator 270 define a first channel 274 and asecond channel 276. Expanding further, when the portion of the housing201 is disposed within the inner volume 279 of the actuator 270, theoutlet port 210 of the housing 201 extends through the first channel 274and the inlet port 208 of the housing 201 extends through the secondchannel 276. In this manner, the outlet port 210 and the inlet port 208of the housing 201 can move within the first channel 274 and the secondchannel 276, respectively, when the actuator 270 is moved between itsfirst position and its second position, relative to the housing 201.

The actuator 270 further includes a tab 277 that can selectively engagethe inlet port 208 when the inlet port 208 is disposed within the secondchannel 276. Expanding further, the tab 277 extends from a surface ofthe wall 273 of the actuator 270 and includes a deformable portion 278that can be deformed to move the tab 277 from a first configuration to asecond configuration, as indicated by the arrow AA in FIG. 6. In thismanner, the tab 277 can selectively limit the movement of the actuator270 from its first position to its second position, relative to thehousing 201. Similarly, the wall 273 of the actuator 270 defining thefirst channel 274 is configured to form a shoulder 275 that can engagethe retention tabs 213 (described above) of the housing 201. Thearrangement of the shoulder 275 and the retention tabs 213 is such thatthe when in contact, the shoulder 275 and the retention tabs 213collectively limit the movement of the actuator 270 from its secondposition to its first position, relative to the housing 201, asdescribed in further detail herein.

As shown in FIGS. 7-9, the flow control mechanism 230 includes a firstcontrol member 231, a second control member 245, a first plunger 255,and a second plunger 260. At least a portion of the flow controlmechanism 230 is movably disposed within the inner volume 207 of thehousing 201. More specifically, the flow control mechanism 230 can bedisposed within the inner volume 207 of the housing 201 such that as theactuator 270 is moved from its first position to its second position,the flow control mechanism 230 is moved between a first, a second, and athird configuration, as further described herein.

As shown in FIG. 7, the first control member 231 is a substantiallycylindrical elongate member and includes a proximal end portion 232 anda distal end portion 233. The distal end portion 233 is disposed withina portion of the first plunger 255. The proximal end portion 232includes a set of protrusions 234 that extend outward from a surface ofthe proximal end portion 232. The protrusions 234 include a proximalsurface 235, which can be placed in contact with a portion of theactuator 270, and a distal surface 236, which can be placed in contactwith a portion of the second control member 245. Therefore, when theactuator 270 is moved from its first position to its second positionrelative to the housing 201, the actuator 270 can move the first controlmember 231 within the inner volume 207. Moreover, the movement of thefirst control member 231 within the inner volume 207 can be such thatthe flow control mechanism 230 is moved between its first, second, andthird configurations, as further described herein. While shown in FIG. 7as including four protrusions 234, in other embodiments, the firstcontrol member 232 can include any suitable number of protrusions 234.For example, in some embodiments, a first control member can includemore than four protrusions. In other embodiments, a first control membercan include fewer than four protrusions.

The second control member 245 includes a proximal end portion 246 and adistal end portion 247, and defines a void 248 therethrough. Theproximal end portion 246 of the second control member 245 includes acollar 249 that is configured to circumscribe the proximal end portion246. Similarly stated, the collar 249 has a diameter that issubstantially larger than the diameter of the proximal end portion 246of the second control member 245. The proximal end portion 246 and thedistal end portion 247 are substantially open such that the secondcontrol member 2.45 is substantially annular. In this manner, the secondcontrol member 245 is configured to be movably disposed about a portionof the first control member 231 (see e.g., FIGS. 8 and 9).

As shown in FIG. 7, the first plunger 255 includes a seal element 257and defines a recess 258. The recess 258 is configured to receive thedistal end portion 233 of the first control member 231, as shown in FIG.8. The first plunger 255 can be any suitable shape, size, orconfiguration. For example, in some embodiments, the first plunger 255can have a diameter that substantially corresponds to an inner diameterof the walls 205 of the housing 201. More specifically, the diameter ofthe first plunger 255 can be substantially larger than the innerdiameter of the walls 205 such that when the first plunger 255 isdisposed within the inner volume 207 of the housing 201, the sealelement 257 forms a substantially fluid tight seal with an inner surfaceof the walls 205. In this manner, the first plunger 255 can fluidicallyisolate a portion of the inner volume 207 that is distal to the firstplunger 255 from a portion of the inner volume 207 that is proximal tothe first plunger 255.

The second plunger 260 includes a proximal end portion 261 and a distalend portion 262, and defines an inner volume 268 therethrough. In thismanner, the second plunger 260 can be disposed about the second controlmember 245. Similarly stated, the second plunger 260 can besubstantially annular and can substantially circumscribe the secondcontrol member 245 such that the second control member 245 is disposedwithin the inner volume 268. The proximal end portion 261 includes afirst seal element 263 that forms a shoulder 264 configured to be placedin contact with the collar 249 (described above) when the second plunger260 is disposed about the second control member 245. Similarly, thedistal end portion 262 includes a second seal element 265 and a thirdseal element 266 configured to form an inner shoulder 267. The innershoulder 267 can be placed in contact with the distal end portion 247 ofthe second control member 245 when the second plunger 260 is disposedabout the second control member 245.

As shown in FIG. 9, the first seal element 263 and the second sealelement 265 are configured to extend beyond an outer surface of thesecond plunger 260. Similarly stated, the first seal element 263 and thesecond seal element 265 have a diameter that is at least slightly largerthan a diameter of a portion of the second plunger 260 that is disposedbetween the first seal element 263 and the second seal element 265.Moreover, the diameter of the first seal element 263 and the second sealelement 265 is configured to be at least slightly larger than the innerdiameter of the walls 205 defining the inner volume 207. Thus, the firstseal element 263 and the second seal element 265 form a substantiallyfluid tight seal with the inner surface of the watts 205. In addition,the diameter of the portion of the second plunger 260 that is disposedbetween the first seal element 263 and the second seal element 265 canbe at least slightly smaller than the inner diameter of the walls 205.Therefore, the portion of the second plunger 260 (between the first andsecond seal elements 263 and 265) and the inner surface of the walls 205define a void 269 that substantially circumscribes the portion of thesecond plunger 260. Furthermore, the first seal element 263 fluidicallyisolates the void 269 from a volume that is distal to the first sealelement 263 and the second seal element 265 fluidically isolates thevoid 269 from a volume that is proximal to the second seal element 265.

The third seal element 266 is configured to extend beyond an innersurface of the second control member 245 such that when the firstcontrol member 231 is disposed within the void 248 of the second controlmember 245 (described above), the third seal element 266 forms asubstantially fluid tight seal with an outer surface of the firstcontrol member 231. In this manner, the first control member 231 can bemoved relative to the second control member 245 while fluidicallyisolating a volume that is proximal to the third seal element 266 from avolume that is distal to the third seal element 266, as furtherdescribed herein.

The arrangement of the second plunger 260 and the second control member245 can be such that the second control member 245 provides structuralrigidity for the second plunger 260. In this manner, the flow controlmechanism 230 can move within the inner volume 207 of the housing 201without the first seal element 263, the second seal element 265, and/orthe third seal element 266 deforming a sufficient amount to disrupt thesubstantially fluid tight seal or seals. While shown in FIGS. 2-12 asincluding a second control member 245 that is independent of the secondplunger 260 (e.g., not monolithically formed), in other embodiments, thesecond plunger 260 and the second control member 245 can bemonolithically formed while maintaining a desired structural rigidity.

Referring back to FIG. 8, the first reservoir 280 can be defined betweena proximal surface of the first plunger 255 and the distal surface ofthe second plunger 260. More specifically, the first reservoir 280 isformed by a portion of the inner volume 207 of the housing 201 that isfluidically isolated between the first plunger 255 (e.g., the sealelement 257) and the second plunger 260 (e.g., the second and third sealelements 265 and 266). In this manner, the first reservoir 280 can be anannular volume between the outer surface of the first control member 231of the flow control mechanism 230 and the inner surface of the walls 205defining the inner volume 207. Thus, the first reservoir 280 can be influid communication with the inlet port 208 of the housing 201 toreceive an amount of a bodily-fluid and fluidically isolate the amountof the bodily-fluid from a volume substantially outside the firstreservoir 280, as further described below.

As shown in FIG. 8, the transfer device 200 is in the firstconfiguration when the actuator 270 is in its first position and theflow control mechanism 230 is in its first configuration. In thismanner, a user can engage the transfer device 200 to couple the inletport 208 to a proximal end portion of a lumen-defining device (notshown) such as, for example, a butterfly needle. With the inlet port 208coupled to the lumen-defining device the inlet lumen 209 is placed influid communication with the lumen defined by the lumen-defining device.Furthermore, the distal end portion of the lumen-defining device can bedisposed within a portion of the body of a patient (e.g., a vein), thus,the inlet lumen 209 is in fluid communication with the portion of thebody of the patient. In a similar manner, the outlet port 210 can becoupled to an external fluid reservoir (not shown). The external fluidreservoir (i.e., the second reservoir) can be any suitable reservoir.For example, in some embodiments, the external fluid reservoir can be aBacT/ALERT® SN or a BacT/ALERT® FA, manufactured by BIOMERIEUX, INC. Theoutlet port 210 can be coupled to a needle and the transfer device 200can include a container shroud (not shown) disposed about the needle andconfigured to receive a portion of the external fluid reservoir andprotect the user from inadvertent needle sticks.

With the inlet port 208 coupled to the lumen-defining device and theoutlet port 210 coupled to the external fluid reservoir, a user canplace the transfer device 200 in the second configuration by moving thetab 277 of the actuator 270 to the second configuration. Morespecifically, the user can apply a force to bend the tab 277 about anaxis defined by the deformable portion 278, thus, the tab 277 bends atthe deformable portion 278, as indicated by the arrow AA in FIG. 6. Inthis manner, the tab 277 is moved relative to the inlet port 208 suchthat the tab 277 no longer limits the movement of the actuator 270relative to the housing 201.

With the tab 277 no longer limiting the movement of the actuator 270,the user can engage the actuator and the engagement portion 212 of thehousing 201 to apply an activation force on the actuator 270. In thismanner, the actuator 270 and a portion of the flow control mechanism 230are moved in the distal direction towards the second position, as shownby the arrow BB in FIG. 10, placing the transfer device in the secondconfiguration. More specifically, in its first configuration, the firstcontrol mechanism 231 is arranged such that the proximal surfaces 235 ofthe protrusions 234 (described above) are in contact with the actuator270 while the distal surfaces 236 of the protrusions 234 are spacedapart from the collar 249 of the second control member 245 (see FIG. 8).In this manner, a portion of the activation force is transferred to thefirst control member 231 to move the first control member 231 in thedistal direction relative to the second control member 245 and thesecond plunger 260. Furthermore, with the distal end portion 233 of thefirst control member 231 disposed within the recess 258 of the firstplunger 255, the first control member 231 moves the first plunger 255 inthe direction of the arrow BB.

With the first plunger 255 forming a substantially fluid tight seal withthe inner surface of the walls 205, the movement of the first plunger255 relative to the housing 201 compresses air disposed within a portionof the inner volume 207 that is distal to the first plunger 255. In thismanner, the vents 214 defined by the housing 201 (described above) canallow the air to exit the portion of the inner volume 207. Thus, thelikelihood of the pressurized air within the portion of the inner volume207 to disrupt the substantially fluid tight seal formed between thefirst plunger 255 and the inner surface of the walls 205 is reduced.Furthermore, the distal movement of the first control member 231 and thefirst plunger 255 relative to the second control member 245 and thesecond plunger 260 such that the height of the first reservoir 280 isincreased (i.e., the volume of the first reservoir 280 is increased).With the first reservoir 280 fluidically isolated (as described above)the increase in the volume produces a negative pressure (i.e., vacuum)within the fluid reservoir 280.

As shown by the arrow CC, the inlet lumen 209 of the inlet port 208defines a fluid flow path such that the fluid reservoir 280 is in fluidcommunication with the inlet port 208. Furthermore, with the inlet port208 coupled to the lumen-defining device the fluid reservoir 280 isplaced in fluid communication with the portion of the patient (e.g., thevein). The negative pressure within the fluid reservoir 280 is such thatthe negative pressure differential introduces a suction force within theportion of the patient. In this manner, a bodily-fluid is drawn into thefluid reservoir 280. In some embodiments, the bodily-fluid can containundesirable microbes such as, for example, dermally-residing microbes.In some embodiments, the bodily-fluid can contain, for example, microbesdislodged from the keratin layer of the skin during the venipuncture.Moreover, the volume of the bodily-fluid drawn into the fluid reservoir280 can be sufficiently large to collect at least a portion of thedermally-residing microbes while being sufficiently small such as to notcompromise culture sensitively (e,g., blood culture sensitivity).

In some embodiments, the magnitude of the suction force can be modulatedby increasing or decreasing the amount of activation force applied tothe actuator 270. For example, in some embodiments, it can be desirableto limit the amount of suction force introduced to a vein. In suchembodiments, the user can reduce the amount of force applied to theactuator 270 to reduce the rate at which the volume of the firstreservoir 280 increases. In this manner, the suction force is reducedwithin the vein of the patient.

With the desired amount of bodily-fluid transferred to the fluidreservoir 280, a user can engage the transfer device 200 to move thetransfer device 200 from the second configuration to the thirdconfiguration, wherein a flow of bodily-fluid is transferred to theexternal reservoir (e.g., such as those described above). In someembodiments, the desired amount of bodily-fluid transferred to the firstreservoir 280 is a predetermined amount of fluid. For example, in someembodiments, the transfer device 200 can be configured to transferbodily-fluid until the pressure within the first reservoir 280 is inequilibrium with the pressure of the portion of the body in which thelumen-defining device is disposed (e.g., the vein). In such embodiments,the equalizing of the pressure between the first reservoir 280 and theportion of the body stops the flow of the bodily-fluid into the firstreservoir 280. In some embodiments, the predetermined amount ofbodily-fluid (e.g., volume) is at least equal to the combined volume ofthe inlet lumen 209 and the lumen-defining device. In some embodiments,the predetermined amount of bodily-fluid can be, for example,approximately 2.25 mL. In other embodiments, the predetermined amount ofbodily-fluid can be between approximately 0.5 mL and approximately 5 mL.Still in other embodiments, the predetermined amount of bodily-fluid canbe as little as a single or few drops of fluid to between approximately0.1 mL and 0.5 mL.

As shown in FIG. 11, the transfer device 200 can be moved from thesecond configuration to the third configuration by further moving theactuator 270 in the distal direction to a third position, as indicatedby the arrow DD. Expanding further, the user can apply an activationforce to the actuator 270 and the engagement portion 212 of the housing201 such that the actuator 270 and the first control member 231 move inthe distal direction. Moreover, as the actuator 270 is moved from thesecond configuration, the distal surfaces 236 of the protrusions 234included in the first control mechanism 231 are brought into contactwith the collar 249 of the second control member 245. Therefore, thefirst control member 231 transfers a portion of the activation force tothe second control member 245 such that the second control member 245and the second plunger 260 move concurrently with the first controlmember 231 and the first plunger 255 (i.e., the flow control mechanism230 moves in the distal direction, relative to the housing 201). Withthe desired amount of the bodily-fluid disposed within the firstreservoir 280 the volume of the first reservoir 280 is configured toremain constant as the flow control mechanism 230 moves relative to thehousing 201. Similarly stated, the pressure within the fluid reservoiris configured to remain substantially unchanged as the transfer device200 is moved from the second configuration to the third configuration.

The actuator 270 is configured to move the flow control mechanism 230within the inner volume 207 of the housing 201 such that the firstreservoir 280 is fluidically isolated from the inlet port 208. Moreover,the flow control mechanism 230 can be moved in the distal direction asufficient amount such that the second seal element 265 of the secondplunger 260 is moved to a distal position relative to the inlet lumen209 defined by the inlet port 208. In addition, the distal movement ofthe flow control mechanism 230 is such that the first seal element 263of the second plunger 260 is maintained in a proximal position relativeto the outlet lumen 211 defined by the outlet port 210. In this manner,the void 269 (described above) is in fluid communication with the inletlumen 209 and the outlet lumen 211.

As shown by the arrow EE, the inlet lumen 209 of the inlet port 208, thevoid 269, and the outlet lumen 211 of the outlet port 210 define a fluidflow path such that the external reservoir (not shown in FIG. 11) is influid communication with the inlet port 208 and, therefore, the portionof the patient (e.g., the vein). Furthermore, the external reservoir isconfigured to define a negative pressure (e.g., the known externalreservoirs referred to herein are vessels defining a negative pressure).The negative pressure within the external reservoir is such that thenegative pressure differential between the external reservoir and theportion of the body of the patient introduces a suction force within theportion of the patient. Therefore, a desired amount of bodily-fluid isdrawn into the external reservoir and is fluidically isolated from thefirst, predetermined amount of bodily-fluid contained within the firstreservoir 280. In this manner, the bodily-fluid contained in theexternal reservoir is substantially free from microbes generally foundoutside of the portion of the patient (e.g., dermally residing microbes,microbes within a lumen defined by the transfer device 200, microbeswithin the lumen defined by the lumen defining device, and/or any otherundesirable microbe). With the desired amount of bodily-fluid containedin the external fluid reservoir, the external reservoir can be decoupledfrom the transfer device 200.

As shown in FIG. 12, the movement of the transfer device 200 to thethird configuration is such that the retention tabs 213 (describedabove) are placed in contact with the shoulder 275 of the actuator 270(described above). The retention tabs 213 and the shoulder 275collectively maintain the transfer device 200 in the thirdconfiguration. Thus, the first amount of bodily-fluid contained withinthe first reservoir 280 is maintained in fluidic isolation from a volumeoutside of the fluid reservoir 280. In this manner, the transfer device200 can be safely discarded or the volume of bodily fluid contained inthe first reservoir 280 can be used for other testing such as, forexample, testing where dermally residing microbes would not affect thetest results.

While the transfer device 200 is shown and described in FIGS. 2-12 asincluding a discrete actuator 270, in some embodiments, a transferdevice can include a fluid reservoir configured to actuate the transferdevice. For example, FIGS. 13-19 illustrate a transfer device 300according to an embodiment. The transfer device 300 includes a housing301, a container shroud 320, a flow control mechanism 330 defining afirst fluid reservoir 380, and a second fluid reservoir 390. Thetransfer device 300 can be any suitable shape, size, or configuration.For example, while shown in FIG. 13 as being substantially cylindrical,the transfer device 300 can be polygonal (rectangular, hexagonal, etc.),oval (elliptical, circular, etc.), and/or any other non-cylindricalshape. As further described below, the transfer device 300 can be movedbetween a first, a second, and a third configuration to deliver a flowof a bodily-fluid that is substantially free from microbes exterior thebody, such as, for example, dermally residing microbes.

As shown in FIGS. 13 and 14, the housing 301 includes a proximal endportion 302, a distal end portion 303, and a tapered portion 304, anddefines an inner volume 307 and an aperture 306. The distal end portion303 is a substantially closed portion of the housing 301 and extends inthe proximal direction towards the tapered portion 304. The proximal endportion 302 of the housing 301 is substantially open such that the innervolume 307 can movably receive the flow control mechanism 330 and atleast a portion of the second fluid reservoir 390. As shown, theproximal end portion 302 has a diameter that is substantially largerthan a diameter of the distal end portion 303 of the housing 301. Inthis manner, the tapered portion 304 extends from the proximal endportion 302 towards the distal end portion 303 at a given angle suchthat the tapered portion 304 is a transitional portion between thelarger diameter of the proximal end portion 302 and the smaller diameterof the distal end portion 303. The aperture 306 defined by the housing301 receives a portion of the flow control mechanism 330, as furtherdescribed herein.

As shown in FIG. 14, the flow control mechanism 330 includes a firstcontrol member 331, a second control member 345, a first plunger 355,and a second plunger 360. As described above, the flow control mechanism330 is configured to be movably disposed within the inner volume 307 ofthe housing 301. More specifically, the flow control mechanism 330 canbe moved within the housing 301 between a first, a second, and a thirdconfiguration.

The first control member 331 has a shape that substantially correspondsto the shape of the housing 301 and includes a proximal end portion 332,a distal end portion 333, and a tapered portion 337 disposedtherebetween. The first control member 331 also defines an inner volume341 (see e.g., FIG. 15) and a channel 338. The distal end portion 333 isa closed portion of the first control member 331 and is coupled to thefirst plunger 355, as further described herein. The proximal end portion332 is substantially open such that the inner volume 341 can receive thesecond control member 345, the first plunger 355, and the second plunger360. The proximal end portion 332 further includes a set of extensions339 that define a set of slots 340. The extensions 339 can be movablydisposed within a portion of the container shroud 320 and can be placedin contact with a portion of the second fluid reservoir 390, as furtherdescribed herein. The channel 338 (FIG. 15) movably receives a portionof the second control member 345, as further described below.

The second control member 345 includes a proximal end portion 346, adistal end portion 347, and defines an inner volume 348. The distal endportion 347 is substantially open such that the inner volume 348 canreceive at least a portion the first plunger 355 and the second plunger360. The proximal end portion 346 includes an inlet port 350 and anoutlet port 352. The inlet port 350 is in fluid communication with theinner volume 348 and extends from a portion of the wall of the secondcontrol member 345 defining the inner volume 348. Moreover, the inletport 350 can be coupled to an adapter 354 (e.g., a Luer-Lok® or thelike) such that when the flow control mechanism 330 is disposed withinthe housing 301, the adapter 354 extends through the channel 338 in thefirst control mechanism 331 and through the aperture 306 defined by thehousing 301. The adapter 354 can further be fluidically coupled to amedical device (not shown) that defines a fluid flow pathway forwithdrawing and/or conveying the bodily-fluid from a patient to thetransfer device 300. For example, the adapter 354 can be fluidicallycoupled to a needle or other lumen-containing device (e.g., flexiblesterile tubing) such that the inlet port 350 is in fluid communicationwith the lumen-containing device. Expanding further, when thelumen-containing device is disposed within a portion of a body of thepatient (e.g., within a vein of the patient), the inner volume 348 ofthe second control member 345 is placed in fluid communication with theportion of the body of the patient. The outlet port 352 included in thesecond control member 345 is configured to be in fluid communicationwith the inner volume 348 and can be fluidically coupled to a portion ofthe container shroud 320, as further described herein.

As shown in FIG. 14, the first plunger 355 includes an elongate portion356 and seal element 357. More specifically, the seal element 357 isdisposed at a proximal end of the elongate portion 356. The seal element357 can be substantially similar to the seal element 257 of the firstplunger 255 described above with reference to FIGS. 7 and 8. Thus, theseal element 357 is configured to form a substantially fluid tight sealwith an inner surface of the second control member 345. The seal element357 can fluidically isolate a portion of the inner volume 348 that isdistal to the first plunger 355 from a portion of the inner volume 348that is proximal to the first plunger 355, as further described herein.The elongate portion 356 is configured to be coupled to the firstcontrol member 331 (e.g., via an adhesive, a mechanical fastener, or anyother suitable coupling method). More specifically, the elongate portion356 is configured to extend in the proximal direction from a surface ofthe first control member 331 (see e.g., FIG. 16).

The second plunger 360 includes a seal portion 363. The second plunger360 is disposed within the inner volume 348 at a proximal positionrelative to the first plunger 355 (see e.g., FIG. 16). The seal member363 is configured to form a substantially fluid tight seal with theinner surface of the second control member 345, as described above.While not shown in FIGS. 13-18, the second plunger 345 is configured tobe coupled to the first plunger 355. For example, in sonic embodiments,the second plunger 345 can be coupled to the first plunger 355 via oneor more tethers. In this manner, the first plunger 355 can be moved afirst distance relative to the second plunger 360 to place the tethersin tension such that further movement of the first plunger 355 alsomoves the second plunger 360, as further described herein.

As shown in FIG. 14, the container shroud 320 includes a proximal endportion 321 and a distal end portion 322. The proximal end portion 321is configured to receive a portion of the second fluid reservoir 390, asfurther described herein. The distal end portion 322 includes a port32.3 that is coupled to the outlet port 352 of the second control member345. In this manner, the port 323 included in the container shroud 320can be placed in fluid communication with the inner volume 348 of thesecond control member 345. As shown in FIG. 16, the port 323 can beconfigured to include a needle 326 configured to pierce a portion of thesecond fluid reservoir 390, as described in further detail herein. Thecontainer shroud 320 is further configured to define a set of apertures324 that movably receive the extensions 329 of the first control member33L Similarly stated, at least a portion of the extensions 339 of thefirst control member 331 can be inserted into the apertures 324 definedby the container shroud 320.

As shown in FIGS. 16-18, the first reservoir 380 can be defined betweena proximal surface of the first plunger 355 and the distal surface ofthe second plunger 360. More specifically, the first reservoir 380 isformed by a portion of the inner volume 348 of the second control member345 that is fluidically isolated between the first plunger 355 (e.g.,the seal element 357) and the second plunger 360 (e.g., the sealelements 363). In this manner, the first reservoir 380 can be placed influid communication with the inlet port 350 of the second control member345 to receive an amount of a bodily-fluid and can fluidically isolatethe amount of the bodily-fluid from a volume substantially outside thefirst reservoir 380, as further described below.

At least a portion of the second reservoir 390 is disposed within thehousing 301. More specifically, a portion of the second reservoir 390 ismovably disposed within the container shroud 320 housed by the housing301. The second reservoir 390 can be any suitable reservoir. Forexample, in some embodiments, the second fluid reservoir 390 can be aBacT/ALERT® SN or a BacT/ALERT® FA, manufactured by BIOMERIEUX, INC. Thesecond reservoir 390 includes a piercable septum 393 that can be piercedby, for example, the needle 326 included in the port 323 of thecontainer shroud 320 such that an inner volume 392 defined by the secondreservoir 390 can receive a flow of the bodily-fluid. Moreover, thesecond reservoir 390 can be moved relative to the housing 301 to actuatethe transfer device 300. Similarly stated, the second reservoir 390 canbe moved relative to the housing 301 to move the transfer device 300between the first, second, and third configurations, as described below.

As shown in FIG. 16, the transfer device 300 is in the firstconfiguration when the second fluid reservoir 390 is in a first position(e.g., a proximal position) relative to the housing 301 and when theflow control mechanism 330 is in its first configuration. In thismanner, a user can engage the transfer device 300 to couple the adapter354 to a proximal end portion of a lumen-defining device (not shown)such as, for example, a butterfly needle. With the adapter 354 coupledto the lumen-defining device, the inlet port 350 is placed in fluidcommunication with the lumen defined by the lumen-defining device.Furthermore, the distal end portion of the lumen-defining device can bedisposed within a portion of the body of a patient (e.g., a vein), thus,the inlet port 350 is in fluid communication with the portion of thebody of the patient.

With the inlet port 350 coupled to the lumen-defining device, a user canplace the transfer device 300 in the second configuration by moving thesecond reservoir 390 in the distal direction relative to the housing301, as indicated by the arrow FF in FIG. 17. More specifically, thedistal movement places a portion of the second reservoir 390 in contactwith the extensions 339 of the first control member 331 such that theextensions 339 move within the apertures 324 defined by the containershroud 320. In this manner, the second reservoir 390 moves the firstcontrol member 331 within the inner volume 307 relative to the secondcontrol member 345.

With the first plunger 355 coupled to the first control member 331, thesecond reservoir 390 also urges the first plunger 355 to move within theinner volume 348 of the second control member 345 such that the flowcontrol mechanism 330 is placed in its second configuration, as shown inFIG. 17. The distal movement of the first control member 331 and thefirst plunger 355 relative to the second control member 345 and thesecond plunger 360 is such that the height of the first reservoir 380 isincreased (i.e., the volume of the first reservoir 380 is increased).With the first reservoir 380 fluidically isolated (as described above),the increase in the volume produces a negative pressure within the fluidreservoir 380.

As shown by the arrow GG, the inlet port 350 defines a fluid flow pathsuch that the fluid reservoir 380 is in fluid communication with theinlet port 350. Furthermore, with the inlet port 350 coupled to thelumen-defining device (e.g., via the adapter 354)) the fluid reservoir380 is placed in fluid communication with the portion of the patient(e.g., the vein). The negative pressure within the fluid reservoir 380is such that the negative pressure differential introduces a suctionforce within the portion of the patient. In this manner, a bodily-fluidis drawn into the fluid reservoir 380. In some embodiments, thebodily-fluid can contain undesirable microbes such as, for example,dermally-residing microbes.

With the desired amount of bodily-fluid transferred to the fluidreservoir 380, a user can move the transfer device 300 from the secondconfiguration to the third configuration, wherein a flow of bodily-fluidis transferred to the second reservoir 390. In some embodiments, thedesired amount of bodily-fluid transferred to the first reservoir 380 isa predetermined amount of fluid. For example, in some embodiments, thetransfer device 300 can be configured to transfer bodily-fluid until thepressure within the first reservoir 380 is in equilibrium with thepressure of the portion of the body in which the lumen-defining deviceis disposed (e.g., the vein). In such embodiments, the equalizing of thepressure between the first reservoir 380 and the portion of the bodystops the flow of the bodily-fluid into the first reservoir 380. In someembodiments, the predetermined amount of bodily-fluid (e.g., volume) isat least equal to the combined volume of the inlet port 350 and thelumen-defining device.

As shown in FIG. 18, the transfer device 300 can be moved from thesecond configuration to the third configuration by further moving thesecond reservoir 390 in the distal direction, as indicated by the arrowHH. The additional movement of the second reservoir 390 in the distaldirection is such that the port 323 of the container shroud 320 isbrought into contact with the second reservoir 390. More specifically,the needle 326 of the port 323 pierces the piercable septum 393 of thesecond reservoir 390 to place the port 323 in fluid communication withthe inner volume 392 of the second reservoir 390.

In addition, as the second reservoir 390 is moved from the secondconfiguration, the tethers (not shown) between the first plunger 355 andthe second plunger 360 are placed in tension. Therefore, the firstplunger 355 transfers a portion of the activation force (e.g., appliedon the second reservoir 390 by the user) to the second plunger 360. Inthis manner, the second plunger 360 is moved concurrently with the firstcontrol member 331 and the first plunger 355 (e.g., the flow controlmechanism 330 is moved to its third configuration). With the desiredamount of the bodily-fluid disposed within the first reservoir 380 thevolume of the first reservoir 380 is configured to remain constant asthe flow control mechanism 330 moves relative to the housing 301.Similarly stated, the pressure within the fluid reservoir is configuredto remain substantially unchanged as the transfer device 300 is movedfrom the second configuration to the third configuration.

When the flow control mechanism 330 is moved toward its thirdconfiguration, the first control member 331 is configured to move thefirst plunger 355, and the second plunger 360 within the inner volume348 of the second control member 345 such that the first reservoir 380is fluidically isolated from the inlet port 350. Moreover, the secondplunger 360 can be moved in the distal direction a sufficient amountsuch that the second plunger 360 is moved to a distal position relativeto the inlet port 350.

With the second plunger 360 in the distal position relative to the inletport 350, the inlet port 350, a portion of the inner volume 348, theoutlet port 350, and the port 323 define a fluid flow path, as indicatedby the arrow II. In this manner, the inner volume 392 of the secondreservoir is placed in fluid communication with the inlet port 350 and,therefore, the portion of the patient (e.g., the vein). Furthermore, thesecond reservoir 390 is configured to define a negative pressure (e.g.,the known reservoirs referred to herein are vessels defining a negativepressure) such that the negative pressure differential between thesecond reservoir 390 and the portion of the body of the patientintroduces a suction force within the portion of the patient. Therefore,a desired amount of bodily-fluid is drawn into the inner volume 392 ofthe second reservoir 390 and is fluidically isolated from the first,predetermined amount of bodily-fluid contained within the firstreservoir 380. In this manner, the bodily-fluid contained in the secondreservoir 390 is substantially free from microbes generally foundoutside of the portion of the patient (e.g., dermally residing microbes,microbes within a lumen defined by the transfer device 300, microbeswithin the lumen defined by the lumen defining device, and/or any otherundesirable microbe). With the desired amount of bodily-fluid containedin the second reservoir 390, the second reservoir 390 can be decoupledfrom the transfer device 300. Furthermore, the first amount ofbodily-fluid contained within the first reservoir 380 is maintained influidic isolation from a volume outside of the fluid reservoir 380. Inthis manner, the transfer device 300 can be safely discarded.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods and steps described above indicate certainevents occurring in certain order, those of ordinary skill in the arthaving the benefit of this disclosure would recognize that the orderingof certain steps may be modified and that such modifications are inaccordance with the variations of the invention. Additionally, certainof the steps may be performed concurrently in a parallel process whenpossible, as well as performed sequentially as described above.Additionally, certain steps may be partially completed and/or omittedbefore proceeding to subsequent steps.

While various embodiments have been particularly shown and described,various changes in form and details may be made. For example, althoughvarious embodiments have been described as having particular featuresand/or combinations of components, other embodiments are possible havingany combination or sub-combination of any features and/or componentsfrom any of the embodiments described herein.

The specific configurations of the various components can also bevaried. For example, the size and specific shape of the variouscomponents can be different than the embodiments shown, while stillproviding the functions as described herein. More specifically, the sizeand shape of the various components can be specifically selected for adesired rate of bodily-fluid flow into a fluid reservoir.

1.-30. (canceled)
 31. A blood sequestration device, comprising: ahousing having an inlet port configured to be fluidically coupled to apatient and an outlet port configured to be fluidically coupled to asample reservoir; a fluid reservoir disposed in the housing and at leastpartially defined by a seal member, the fluid reservoir configured toreceive an initial volume of blood withdrawn from the patient; and avent disposed in the housing and configured to allow air to exit thehousing as blood enters the fluid reservoir, the blood sequestrationdevice configured to allow the initial volume of blood to flow from theinlet port to the fluid reservoir, the blood sequestration devicefurther configured to allow a subsequent volume of blood to flow fromthe inlet port toward the outlet port via a sampling flow path, therebybypassing the fluid reservoir and the initial volume of bloodsequestered therein.
 32. The blood sequestration device of claim 31,wherein the initial volume of blood is less than approximately 5 ml. 33.The blood sequestration device of claim 31, wherein the initial volumeof blood is less than approximately 0.5 ml.
 34. The blood sequestrationdevice of claim 31, wherein the initial volume of blood is approximately0.1 ml to approximately 0.5 ml.
 35. The blood sequestration device ofclaim 31, wherein the outlet port is fluidically isolated from the fluidreservoir.
 36. The blood sequestration device of claim 31, wherein theseal member is configured to prevent the flow of air through the ventinto the fluid reservoir.
 37. The blood sequestration device of claim31, wherein the initial volume of blood is fluidically isolated in thefluid reservoir.
 38. The blood sequestration device of claim 31, whereinthe blood sequestration device is configured to automatically transitionfrom a first operating mode in which the initial volume of blood isallowed to flow from the inlet port to the fluid reservoir, to a secondoperating mode in which the subsequent volume of blood is allowed toflow from the inlet port toward the outlet port via the sampling flowpath.
 39. A blood sequestration device, comprising: a housing having aninlet port configured to be fluidically coupled to a patient and anoutlet port configured to be fluidically coupled to a sample reservoir;a first fluid flow path disposed in the housing and configured to allowan initial volume of blood to flow from the inlet port to a fluidreservoir defined at least partially by the housing; a vent disposed inthe housing and configured to allow air to exit the housing as bloodenters the fluid reservoir; a second fluid flow path disposed in thehousing and configured to allow a subsequent volume of blood to flowfrom the inlet port toward the outlet port; the blood sequestrationdevice configured to transition from a first operating mode in which theinitial volume of blood is allowed to flow from the inlet port to thefluid reservoir via the first fluid flow path, to a second operatingmode in which the subsequent volume of blood is allowed to flow from theinlet port toward the outlet port via the second fluid flow path,thereby bypassing the fluid reservoir and the initial volume of bloodsequestered therein.
 40. The blood sequestration device of claim 39,wherein the initial volume of blood is less than approximately 5 ml. 41.The blood sequestration device of claim 39, wherein the initial volumeof blood is less than approximately 0.5 ml.
 42. The blood sequestrationdevice of claim 39, wherein the initial volume of blood is approximately0.1 ml to approximately 0.5 ml.
 43. The blood sequestration device ofclaim 39, wherein the outlet port is fluidically isolated from the fluidreservoir.
 44. The blood sequestration device of claim 39, wherein theinitial volume of blood is fluidically isolated in the fluid reservoir.45. The blood sequestration device of claim 39, wherein the fluidreservoir is at least partially defined by a seal member disposed in thehousing.
 46. The blood sequestration device of claim 45, wherein theseal member is configured to prevent the flow of air from flowing fromthrough the vent into the fluid reservoir.
 47. The blood sequestrationdevice of claim 39, wherein the blood sequestration device is configuredto transition from the first operating mode to the second operating modewithout manual intervention.
 48. A blood sequestration device,comprising: a lumen-containing device configured to be fluidicallycoupled to a patient; a housing having an inlet port configured to befluidically coupled to the lumen-containing device, and an outlet portconfigured to be fluidically coupled to a sample reservoir; and areservoir at least partially defined by the housing, the reservoirconfigured to receive an initial volume of blood withdrawn from thepatient, the reservoir configured to transition from a first state suchthat the initial volume of blood flows from the inlet port toward a sealdefining a portion of the reservoir, to a second state such that asubsequent volume of blood can flow from the inlet port toward theoutlet port, thereby bypassing the reservoir and the initial volume ofblood sequestered therein.
 49. The blood sequestration device of claim48, wherein the initial volume of blood is less than approximately 5 ml.50. The blood sequestration device of claim 48, wherein the initialvolume of blood is less than approximately 0.5 ml.
 51. The bloodsequestration device of claim 48, wherein the initial volume of blood isapproximately 0.1 ml to approximately 0.5 ml.
 52. The bloodsequestration device of claim 48, further comprising: a vent disposed inthe housing and configured to allow air to exit the housing as bloodenters the reservoir.
 53. The blood sequestration device of claim 52,wherein the seal is configured to prevent the flow of air through thevent into the reservoir.
 54. The blood sequestration device of claim 48,wherein the initial volume of blood is fluidically isolated in thereservoir.
 55. A blood sequestration device, comprising: alumen-containing device configured to be fluidically coupled to apatient; and a housing having an inlet port configured to be fluidicallycoupled to the lumen-containing device, and an outlet port configured tobe fluidically coupled to a sample reservoir, the housing defining afirst fluid flow path and a second fluid flow path, the housingconfigured to transition from a first operating mode in which an initialvolume of blood is allowed to flow from the inlet port toward a seal viathe first fluid flow path, to a second operating mode in which asubsequent volume of blood is allowed to flow from the inlet port towardthe outlet port via the second fluid flow path, the seal configured totransition from a first state to a second state to place the housing inthe second operating mode such that the subsequent volume of blood canflow toward the outlet port via the second fluid flow path and bypassthe initial volume of blood sequestered in the first fluid flow path.56. The blood sequestration device of claim 55, wherein the initialvolume of blood is less than approximately 5 ml.
 57. The bloodsequestration device of claim 55, wherein the initial volume of blood isless than approximately 0.5 ml.
 58. The blood sequestration device ofclaim 55, wherein the initial volume of blood is approximately 0.1 ml toapproximately 0.5 ml.
 59. The blood sequestration device of claim 55,wherein the initial volume of blood is fluidically isolated in the firstfluid flow path.
 60. The blood sequestration device of claim 55, furthercomprising: a vent disposed in the housing and configured to allow airto exit the housing as blood enters the first fluid flow path.